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Pharmacokinetics and Clinical Research Leader
2 months ago
We are seeking a highly experienced and skilled Director/Senior Director of Pharmacokinetics and Clinical Pharmacology to join our team at Recruits Lab. As a key member of our organization, you will play a pivotal role in shaping the future of oncology medicine.
Key Responsibilities- Lead Clinical Pharmacology Programs: Provide expert guidance on all aspects of clinical pharmacology programs supporting drug discovery and clinical development.
- Author Regulatory Documents: Author clinical protocols, study reports, and data analyses (exposure/efficacy/safety) to support the development and registration of new products.
- Apply Pharmacometrics Methodologies: Apply state-of-the-art pharmacometrics methodologies, including population pharmacokinetic and pharmacokinetic-pharmacodynamic modeling, exposure-response analyses, and physiological-based pharmacokinetic modeling.
- Ensure Timely Delivery: Ensure adherence to timelines and budgets for clinical pharmacology studies and programs.
- Lead Scientific Publications: Lead the writing of scientific publications, including abstracts, posters, oral presentations, and manuscripts.
- Manage External Resources: Engage and manage CROs to support pharmacometrics analyses and ensure compliance with agreed protocols, quality standards, and timelines.
- A Ph.D. or PharmD with a minimum of 10 years of industry experience in pharmaceutical sciences, pharmacokinetics, clinical pharmacology, chemistry, or related fields.
- Extensive experience in pharmacometrics analysis, including study design, data analysis, and modeling simulation.
- Proficiency in modeling software packages such as Phoenix WinNonlin, NONMEM, R, SAS, or similar tools.
- Strong knowledge of model-informed drug development, DMPK-Clinical Pharmacology concepts, and regulatory requirements.
- Experience in managing external resources, including CROs and consultants.
- Excellent interpersonal, organizational, and teamwork skills are required to communicate effectively with external collaborators and internal project teams.
- Competitive salary range: $223,449 - $337,470 per year (Director level) | $273,771 - $337,470 per year (Senior Director level).
- Comprehensive benefits package, including medical/dental/vision coverage, retirement benefits, ESPP, and wellness programs.
- Annual bonus and equity refresh for full-time employees.
- An inclusive and collaborative work environment where your ideas are valued and your voice is heard.
